Meta-analysis of transcranial direct current stimulation in improving lower limb motor dysfunction in stroke patients

doi:10.12307/2025.786

Abstract

Abstract: OBJECTIVE: To systematically evaluate the effects of transcranial direct current stimulation on lower limb motor function in patients with stroke.
METHODS: The randomized controlled trials about the effects of transcranial direct current stimulation on patients with stroke were retrieved from databases (PubMed, Web of Science, Embase, Cochrane Library, Scopus, CNKI, VIP, and WanFang Data) from the establishment of the databases to September 22, 2024. RevMan 5.4 software and Stata 14.0 software were used for traditional meta-analysis and network meta-analysis, respectively. GRADE was used to evaluate the level of evidence.
RESULTS: A total of 17 studies involving 851 patients were included. Traditional meta-analysis showed that transcranial direct current stimulation improved the Fugl-Meyer Lower Extremity Motor Function Scale scores [MD=1.97, 95%CI(0.78, 3.16), P < 0.01], Berg Balance Scale scores [MD=3.92, 95%CI(1.67, 6.17), P < 0.01], and Tinetti Balance and Gait Scale score [MD=2.62, 95%CI(0.44, 4.80), P < 0.05], and reduced the Timed Up-and-Go Test time [MD=-1.82, 95%CI (-2.51, -1.12), P < 0.01] and Five Times Sit-To-Stand test time [MD=-0.78, 95%CI(-1.31, -0.26), P < 0.01]. Network meta-analysis showed that transcranial direct current stimulation was more effective in the treatment of lower limb motor function in stroke patients aged 50-60 years with a disease duration of ≤ 6 months, and that a treatment regimen with a current intensity of 2 mA, a treatment duration of > 30 minutes per day, and a period of intervention of > 3 weeks was more effective in the improvement of lower limb motor ability in stroke patients.
CONCLUSION: Current evidence suggests that transcranial direct current stimulation has a better therapeutic effect on lower limb motor function, walking ability, and balance in patients with stroke, in which the improvement of lower limb motor function is affected by the patient’s age and duration of the disease, and there is a dose-response relationship between the current intensity, the duration of the daily treatment time, and the cycle of the intervention to a certain extent.

中国组织工程研究杂志出版内容重点：组织构建；骨细胞；软骨细胞；细胞培养；成纤维细胞；血管内皮细胞；骨质疏松；组织工程

Key words: stroke, balance, walking, lower limb, motor, dysfunction, transcranial direct current stimulation, meta-analysis

CLC Number:

Wang He, Yu Shaohong, . Meta-analysis of transcranial direct current stimulation in improving lower limb motor dysfunction in stroke patients[J]. Chinese Journal of Tissue Engineering Research, 2025, 29(30): 6556-6565.

Figures/Tables 10

2.1 文献检索流程及结果初检共获得相关文献1 774篇，剔除重复文献和无法获取的文献481篇，通过阅读文献标题和摘要剔除1 216篇文献，通过阅读全文剔除60篇文献，最终共纳入17篇随机对照试验。文献检索流程及结果见图2。 2.2 纳入研究的基本特征最终纳入17项研究[7，22-37]，发表时间在2012-2024年，涉及851例患者，受试者平均年龄在50岁以上。所纳入研究中，有13项研究采用FMA-LE量表评估下肢运动功能[23，26-37]；2项研究采用FTSTS评估患者的下肢功能性肌肉力量[7，26]，8项研究采用TUGT评估步态功能[7，22，25-27，31-32，34]；2项研究[22，31]、5项研究分别采用POMA量表和BBS量表评估移动能力、平衡能力和跌倒风险[24，27-28，32，35]。纳入研究基本特征见表1。 2.3 纳入文献的质量评价 14项研究报告了具体的随机方法(包括随机数字表法、随机信封盲法分组)[17，22-28，31，33-37]；3项研究随机分组但未提及具体随机方法[29-30，32]。13项研究在治疗过程中对患者或治疗师采用盲法[7，22-28，31-34，36]，8项研究有病例中途退出或失访[25-28，30，32，34，36]，文中均指明具体脱落原因。风险偏倚评估结果见图3和图4。 2.4 传统Meta分析结果 2.4.1 FMA-LE 纳入13篇文献[23，26-37]，共涉及773例患者，其中试验组388例，对照组385例。I2=93%，P > 0.1，各研究间异质性较大，采用随机效应模型分析。结果显示，经颅直流电刺激能够显著提高脑卒中患者的FMA-LE评分[MD=1.97，95%CI(0.78，3.16)，P < 0.01]，见图5。 2.4.2 TUGT 纳入8篇文献[7，22，25-27，31-32，34]，共涉及348例患者，其中试验组175例，对照组173例。I2=39%，P=0.12，各研究间异质性小，采用固定效应模型分析。结果显示，经颅直流电刺激能够显著降低脑卒中患者的TUGT时间[MD=-1.82，95%CI (-2.51，-1.12)，P < 0.01]，见图6。 2.4.3 BBS 纳入5篇文献[24， 27-28，32，35]，共涉及265例患者，其中试验组133例，对照组132例。I2=69%，P=0.01，各研究间异质性较大，采用随机效应模型分析。结果显示，经颅直流电刺激能够提高脑卒中患者的BBS评分[MD=3.92，95%CI(1.67，6.17)，P < 0.01]，见图7。 2.4.4 POMA 纳入2篇文献[22，31]，共涉及44例患者，其中试验组22例，对照组22例。I2=0%，P=0.89，各研究间异质性小，采用固定效应模型分析。结果显示，经颅直流电刺激能够提高脑卒中患者的POMA评分[MD=2.62，95%CI(0.44，4.80)，P < 0.05]，见图8。 2.4.5 FTSTS 纳入2篇文献[7，26]，共涉及49例患者，其中试验组25例，对照组24例。I2=39%，P=0.20，各研究间异质性小，采用固定效应模型分析。结果显示，经颅直流电刺激能够降低脑卒中患者的FTSTS时间[MD=-0.78，95%CI( -1.31，-0.26)，P < 0.01]，见图9。"

FMA-LE评分的亚组进行网状Meta分析。①在年龄组别方面，经颅直流电刺激对于年龄50-60岁、61-70岁脑卒中患者FMA-LE评分的改善效果均优于对照组(P < 0.05)，其余组别间比较无显著性差异(P > 0.05)；②在病程组别方面，经颅直流电刺激对病程≤ 6个月脑卒中患者FMA-LE评分的改善效果优于对照组(P < 0.05)，其余组别间比较无显著性差异(P > 0.05)；③在电流强度组别方面，2 mA电流强度的经颅直流电刺激对脑卒中患者FMA-LE评分的改善效果优于对照组(P < 0.05)，其余组别间比较无显著性差异(P > 0.05)；④在每天治疗时间组别方面，每天≤ 30 min的经颅直流电刺激和每天> 30 min的经颅直流电刺激对脑卒中患者下肢运动功能改善效果均优于对照组(P < 0.05)，且每天≤ 30 min与每天> 30 min两组间比较有显著性差异(P < 0.05)；⑤在治疗周期组别方面，经颅直流电刺激治疗周期> 3周对脑卒中患者FMA-LE评分的改善效果优于对照组(P < 0.05)，其余组别间比较无显著性差异(P > 0.05)，见图10。 2.6.2 概率排序根据累计排序概率曲线下面积，对不同亚组的治疗效果进行排序。结果显示，经颅直流电刺激对于50-60岁、病程≤ 6个月的脑卒中患者下肢运动功能干预效果更好；电刺激强度为2 mA、每天治疗时间> 30 min、干预周期> 3周的经颅直流电刺激治疗方案对于脑卒中患者的下肢运动功能改善效果更佳，见图11。 2.7 敏感性分析采用逐一剔除法，对FMA-LE评分和BBS评分这2项具有高异质性的结局指标进行敏感性分析。 2.7.1 FMA-LE评分剔除张胜利[37]研究后，I2由93%降至88%，FMA-LE评分的合并效应[MD=1.62，95%CI (0.55-2.69)，P < 0.01]，试验组与对照组相比有显著性差异；剔除PRATHUM等[26]研究后，I2由93%降至89%，FMA-LE评分的合并效应[MD=2.49，95%CI(1.41，3.56)，P < 0.01]，试验组与对照组相比有显著性差异。剔除其他单个研究后合并效应MD的范围为1.75-2.49，I2的范围稳定在93%，P < 0.05，说明FMA-LE评分的合并效应"

MD和I2值在稳定范围内，合并结果的稳健性较好，见表3。经分析发现，张胜利[37]研究中的脑卒中患者每次接受30 min的经颅直流电刺激治疗，而其他研究的患者每次接受20 min的经颅直流电刺激治疗，提示单次治疗时间可能为异质性来源之一；PRATHUM等[26]研究的干预场地为患者家中，由患者本人进行经颅直流电刺激干预，在治疗初期提供口头反馈，治疗后期则改为远程监护以确保运动程序的科学和安全，而其他研究的干预场地为医疗中心，由康复治疗师全程进行经颅直流电刺激干预，提示干预场地和干预人员可能为异质性来源。 2.7.2 BBS评分剔除王嘉琳等[27]研究后，I2由69%降至0%，试验组BBS评分显著高于对照组[MD=2.68，95%CI(2.45，2.92)，P < 0.01]，试验组与对照组相比有显著性差异；剔除张海泉等[28]研究后，I2由69%降至55%，试验组BBS评分显著高于对照组[MD=4.51，95%CI(1.62，7.40)，P < 0.01]，试验组与对照组相比有显著性差异。剔除其他单个研究后合并效应MD的范围为2.01-2.83，I2的范围为75%-77%，P均< 0.01，说明BBS评分的合并效应MD和I2在稳定范围内，合并结果稳健性较好，见表3。经分析发现，王嘉琳等[27]研究的脑卒中患者年龄为60岁以上，而其他研究患者年龄均为60岁以下，提示年龄可能为异质性来源之一；张海泉等[28]研究的经颅直流电刺激阴极电极片放置于健侧大脑初级运动皮质区，而其他研究的阴极电极片则放置于健侧眼眶区，提示经颅直流电刺激的阴极电极片放置部位可能是异质性来源之一。 2.8 发表偏倚评估对纳入研究数≥10篇的FMA-LE结局指标进行发表偏倚评估。由图可见，漏斗图对称性欠佳，提示可能存在发表偏倚，且部分黑点落在漏斗图底部及外侧，提示可能存在小样本效应，见图12。 2.9 证据等级评价对纳入研究进行GRADE证据等级评价，结果显示，TUGT、POMA和FTSTS结局指标的证据质量为中级，FMA-LE和BBS结局"

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